Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger

Trigger Finger Clinical Trial

Official title:

Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04855942
• Other study ID #: (811)109A-50
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2022
• Source: Cheng-Hsin General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.

Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Quinnel classification grade 2 or 3

• who has only one trigger

Exclusion Criteria:

• who had ever treated the trigger finger

• who has other musculoskeletal disease of the upper limb

• who has severe coagulopathy disease

• who is pregnant

• who has arrhythmia or has a pacemaker

• there is sensory impairment, scar, edema at the trigger finger

• who has cognitive dysfunction

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis
• Trigger Finger
• Trigger Finger Disorder

Intervention

Device:
• Focused Extracorporeal Shock Wave Therapy (ESWT)
2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
• physiotherapy
therapeutic ultrasound, 12 times in 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cheng-Hsin General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quinnell stages of triggering	Quinnell stages of triggering classifies the trigger finger using five types during flexion and extension: normal movement (Type 0), uneven movement (Type I), actively correctable (Type II), passively correctable (Type III) and fixed deformity (Type IV).	15 weeks
Primary	11-point numeric scale of pain	The 11-point numeric scale of pain requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain imaginable.	15 weeks
Primary	Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)	This questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The investigators chose the first two components: the disability and symptom section (11 items, scored 1-5). The lower score means better condition of upper limbs, and vice versa.	15 weeks
Primary	strength of hand grip	The strength of hand grip is to measure the maximum isometric strength of the hand and forearm muscles by a electicial grip strength device.	15 weeks
Primary	sonographic image	The investigators would record the characteristics of acquired sonographic images, such like the thickness of finger flexor tendon and A1 pulley, the presence of tendon sheath effusion, and the presence of increased vascularity by Doppler images.	15 weeks